Chemotherapy-induced Anemia Clinical Trial
— SYNERGYOfficial title:
Pharmaco-epidemiological Study on the Effect of Retacrit® on Chemotherapy Induced Anaemia in Standard Oncology and Haematology Practice: Impact of Concomitant Iron Supplementation
The aim of this study is to describe, in a real-life context, the impact of an epoetin alpha biosimilar, Retacrit®, on anaemia in patients receiving chemotherapy, according to concomitant iron supplementation.
| Status | Completed |
| Enrollment | 2167 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult patients, aged 18 years and older, seen by the oncologist or hematologist for chemotherapy. - Patients for whom the oncologist or hematologist has decided the initiation of an epoetin alpha biosimilar treatment (Retacrit®) for anemia. - Patients informed about the computer processing of their medical data and their right of access and correction. Exclusion Criteria: - Patients with hemoglobin concentrations >11 g/dL. - Patients who have been transfused within the previous month. - Patients who are hypersensitive to erythropoietin or one of its excipients. - Patients participating or having participated in the previous month in a clinical trial in the field of anaemia in oncology. - Patients refusing to participate in the observational study. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Ch Du Pays D'Aix | Aix En Provence | Marseille |
| France | Clinique Rambot | Aix En Provence | Marseille |
| France | MEDIPOLE | Aix Les Bains | Rhone Alpes |
| France | CHG | Ales | Languedoc |
| France | Ico Angers | Angers | Pays de La Loire |
| France | CHRA | Annecy | Rhone Alpes |
| France | Victor Dubos | Argenteuil | Paris Nord |
| France | Clinique des Bonnettes | Arras | Nord |
| France | Ch Duffaut | Avignon | Marseille |
| France | CH Boulogne-sur-Mer | Boulogne | Nord |
| France | Clinique CONVERT | Bourg en bresse | Rhone Alpes |
| France | CHG Cahors | Cahors | Midi Pyrennees |
| France | CHG | Carcassonne | Languedoc |
| France | CHG William MOREY | Chalon S/s | Bourgogne |
| France | Ch Chambery | Chambery | Rhone Alpes |
| France | Chu Estaing | Clermont | Massif Central |
| France | Chu Gabriel Montpied | Clermont | Massif Central |
| France | Pole Sante Republique | Clermont | Massif Central |
| France | BEAUJON | Clichy | Paris Ouest |
| France | Hopital Louis Pasteur | Colmar | Alsace |
| France | CHU du BOCAGE | Dijon | Bourgogne |
| France | Clinique Pasteur | Evreux | Haute Normandie |
| France | Chi Frejus - St Raphael | Frejus | Paca |
| France | Chu Grenoble | Grenoble | Rhone Alpes |
| France | Hopital Mignot | Le Chesnay | Paris Ouest |
| France | Ch Le Mans | Le Mans | Pays de La Loire |
| France | Victor Hugo | Le Mans | Pays de La Loire |
| France | Hopital Franco Britannique | Levallois Perret | Paris Ouest |
| France | Centre Oscar Lambret | Lille | Nord |
| France | Hopital Des Courses | Maisons Laffitte | Paris Ouest |
| France | Chu Timone | Marseille | |
| France | Fondation Saint Joseph | Marseille | |
| France | Hopital A.Pare | Marseille | |
| France | IPC | Marseille | |
| France | Clinique St Faron | Meaux | Champagne |
| France | CH Jacques Monod | Montivilliers | Haute Normandie |
| France | Clinique Vitalia Desertines | Montlucon | Massif Central |
| France | Chu St Eloi | Montpellier | Languedoc |
| France | CH Emile Muller | Mulhouse | Alsace |
| France | HARTMANN | Neuilly/seine | Paris Ouest |
| France | Clinique Belvédère | Nice | Paca |
| France | CHU Caremeau | Nimes | Languedoc |
| France | Clinique Ste Marie | Osny | Paris Nord |
| France | Saint Antoine | Paris | Paris Nord |
| France | Saint Louis | Paris | Paris Nord |
| France | TENON | Paris | Paris Nord |
| France | Hpt Rene Dubos | Pontoise | Paris Nord |
| France | Cac Jean Godinot | Reims | Champagne |
| France | Chu Rennes | Rennes | Basse Normandie |
| France | CHU SUD | Rennes | Basse Normandie |
| France | Clinique St Laurent | Rennes | Basse Normandie |
| France | CHR | Roanne | Massif Central |
| France | Icl St Etienne | St Etienne | Massif Central |
| France | CHG St Gaudens | St Gaudens | Midi Pyrennees |
| France | Chp St Greg | St Gregoire | Basse Normandie |
| France | Ch St Malo | St Malo | Basse Normandie |
| France | Hopital St Quentin | St Quentin | Champagne |
| France | CAC Paul Strauss | Strasbourg | Alsace |
| France | Chu Hopital Civil | Strasbourg | Alsace |
| France | Hopital Foch | Suresnes | Paris Ouest |
| France | Clinique de l'Ormeau | Tarbes | Midi Pyrennees |
| France | CH Sainte Musse | Toulon | Paca |
| France | H.I.A Saint Anne | Toulon | Paca |
| France | CHU Purpan | Toulouse | Midi Pyrennees |
| France | Clinique Pasteur | Toulouse | Midi Pyrennees |
| France | Inst. Claudius Regaud | Toulouse | Midi Pyrennees |
| France | Hopital Troyes | Troyes | Champagne |
| France | Ch Valence | Valence | Rhone Alpes |
| France | Clinique des Dentellieres | Valenciennes | Nord |
| Lead Sponsor | Collaborator |
|---|---|
| Hospira, Inc. |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Impact of an epoetin alpha biosimilar with or without iron supplementation on chemotherapy-induced anemia | The efficiency of epoetin alpha biosimilar will be assessed by the responders'rate according to European Society for Medical Oncology (ESMO) guidelines. This rate will be compared depending on the iron supplementation. The safety will be assessed by the record of adverse effects (serious or not) and treatment discontinuation. |
Patients are included at the time of the epoetin alpha biosimilar treatment initiation for chemotherapy-induced anemia and followed up to 12 to 16 weeks | Yes |
| Secondary | Characteristics of patients receiving treatment with an epoetin alpha biosimilar, Retacrit®, for chemotherapy induced anaemia | Baseline visit | No | |
| Secondary | Procedures for evaluating possible iron deficiency and iron supplementation | At 12 to 16 weeks from baseline or at the end of chemotherapy | No | |
| Secondary | Impact of iron supplementation on the doses of Retacrit® used, and on treatment duration | At 12 to 16 weeks from baseline or at the end of chemotherapy | Yes | |
| Secondary | Experience of patients treated with Retacrit® | At 12 to 16 weeks from baseline or at the end of chemotherapy | No |